Commissioning and Qualification (C&Q), CQV Strategy Development, FAT, Pre-Commissioning, Qualification Protocols, Construction Turnover, Vendor Management, Change Control, Risk Management, API Manufacturing, GMP Compliance, Kneat, 21 CFR Part 11, Operational Readiness, and Project Coordination. Preferred: Pharmaceutical/biotech experience, API manufacturing CQV, projects exceeding $100 million, Kneat or similar electronic qualification platforms, 21 CFR Part 11 knowledge and a master's degree.